Associate Scientist- Sample Management

Posted 18 February by Darwin Rhodes
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Job Title: Associate Scientist- Sample Management
Job Duration: 12 months
Job Location: Cork, Ireland


Description:
Position Title: Associate Scientist - Analytical Operations Sample Management (Days)
Department: Discovery , Product Development and Supply; BioTherapeutics Analytical Development - Clinical Release and Stability (DPDS, BioTD-AD)
Report to: BioTD-AD Laboratory Management

Position Summary
Global Clinical Release & Stability is a department of Discovery , Product Development and Supply; BioTherapeutics Analytical Development - (DPDS, BioTD-AD).
The department is responsible for Tox Release testing, Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management.

Main duties and responsibilities:

  • Responsible for coordinating sample receipt, distribution and shipping of samples as well as inventory management activities in accordance with GLP practices.
  • Complete logging of samples for release and stability testing.
  • Complete stability pulls as per defined schedules.
  • Complete aliquoting of samples for distribution.


Including, but not limited to:

  • Ensure all activities follow SOP's/WI's and protocols where appropriate and are performed in compliance with regulatory guidelines.
  • Perform sample management activities according to local procedures and processes in a timely and organized fashion.
  • Record all laboratory data in accordance with cGMP and local procedures.
  • Keep up to date with existing and new SOP's and official documentation.
  • Daily management of the routine sample management operations.
  • Responsible for the management of stability inventory.
  • Organize stability inventory and maintain stability chambers.
  • Develop subject matter expertise on assigned role.
  • Use of laboratory software such as LIMS, SAP, SDMS, Trackwise, etc.
  • Contribute to proper use, calibration and maintenance of laboratory equipment.
  • Perform investigations, where required, for deviations, laboratory investigations etc.
  • Independently write/revise SOP's or other official documentation and reports, when required.
  • Execute independently and/or as part of a team, assigned projects/tasks.
  • Train/coach other/new personnel.
  • Lead/participate in lean innovation and continuous improvement projects
  • Perform other duties as designated by Laboratory Management.


Education and Experience/Competencies

  • Knowledge of laboratory sample management and/or stability material is preferred.
  • Industry experience (GMP laboratory) is desirable.
  • Experience with LIMS systems is desirable.


Key Skill Requirements: excellent attention to detail, good communication skills (written & verbal), ability to think logically, proactive approach, ability to work well within team structures, ability to work on own initiative.

Required skills

  • FDA
  • GLP
  • GMP
  • Inventory Management
  • Sample Management

Reference: 37306512

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